MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for MONOMAX VIOLET 2/0 (3) 150CM HR26 (M) B0041444 manufactured by B.braun Surgical Sa.
[63611887]
(b)(4). Manufacturing site evaluation: samples received: 11 unopened pouches and 1 opened pouch. Analysis and results: there are no previous complaints of this code batch. Manufactured and distributed (b)(4) units of this code batch. There are no units in stock. Received eleven closed samples and one open sample (only the second pack is open). The first pack (aluminum pouch) on the open sample received is not sealed/glued to the peel foil. Opened all closed packs received and the aluminum pouch was not stuck to the outer paper foil. All packs have been opened correctly. Defective samples are needed to show the defect to asses properly the customer complaint. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements. Final conclusion: complaint is not justified. The results of the samples received fulfill the oem specifications. Note is taken of this incident in order to assess if new or additional actions are needed. Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions. Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
Patient Sequence No: 1, Text Type: N, H10
[63611888]
Country of complaint: (b)(6). It was reported that the first pack was sealed to the second pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2016-00025 |
| MDR Report Key | 6201182 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-21 |
| Date Facility Aware | 2016-12-12 |
| Date Mfgr Received | 2016-11-23 |
| Date Added to Maude | 2016-12-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | B.BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONOMAX VIOLET 2/0 (3) 150CM HR26 (M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2016-12-22 |
| Returned To Mfg | 2016-12-12 |
| Model Number | B0041444 |
| Catalog Number | B0041444 |
| Lot Number | 115511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-22 |